NCT04866433

The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine

The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine During Spinal Anesthesia: a Randomized, Placebo-controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate whether real-time binaural sound affects the dose of dexmedetomidine in patients undergoing sedation with dexmedetomidine after spinal anesthesia.

Detailed description

Patients undergoing sedation with dexmedetomidine after spinal anesthesia are randomly assigned to binaural group, audio group, and control group. After spinal anesthesia, SedLine continuous monitoring is started. Real-time binaural sound applied music is played to the binaural group, normal music is played to the audio group, and headphones with no sound are applied to the control group. Observer's Assessment of Alertness/Sedation Scale (OAAS) and Patient State Index (PSi) are checked every minute after loading of dexmedetomidine at the rate of 1 μg/kg for 10 minutes (6 μg/kg/hr). Loading is stopped when the OAAS score is 3 or less. Then, dexmedetomidine is continuously infused at a rate of 0.6 μg/kg/hr, and OAAS is evaluated every 30 minutes. The infusion rate is lowered (-0.1 μg/kg/hr) if OAAS is lower than 3, and increased (+0.1 μg/kg/hr) if OAAS is higher than 3. The continuous infusion rate should not exceed 1 μg/kg/hr. The total dexmedetomidine dose corrected by the patient's predicted body weight and infusion time (μg/kg/hr) was compared between groups. In addition, the loading dose (μg/kg) and continuous infusion dose (μg/kg/hr), additional sedative use, blood pressure, heart rate, ECG changes, respiratory depression, and oxygen saturation were observed. The patient's satisfaction is evaluated after the surgery.

Conditions

• Sedative Adverse Reaction

Interventions

Type	Name	Description
PROCEDURE	Real-time binaural sound	Play music with a frequency difference (real-time binaural sound) in each ear through headphones during sedation.
PROCEDURE	Music	Play the same music in both ears through headphones during sedation
PROCEDURE	Control	Just wear headphones during sedation

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-01-27
• Completion: 2022-02-10
• First posted: 2021-04-29
• Last updated: 2022-03-02

Locations

1 site across 1 country: South Korea